Director of Operations & Site Leader, Transfusion, Warren

Introduction

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Overview

Responsible for manufacturing and supply chain operations and site leadership activities for the Warren, New Jersey Transfusion location. The Director of Operations directs and coordinates a diverse manufacturing and supply chain operation consistent with company schedules, budgets, goals and strategic objectives. This role ensures quality standards, productivity, and overall efficiency of area maintained and/or improved. As Site Leader, this position plays a critical role in fostering a culture of collaboration and continuous improvement, mentoring and developing a diverse team of professionals, acting as the primary point of contact for the site, and managing the overall site budget. This position reports to the VP Operations, Transfusion.

Responsibilities

Key Accountabilities

• Directs and provides leadership for Warren manufacturing (MFG) and supply chain (SC) departments, ensuring high quality products, consistent and reliable supply and delivery, as well as cost efficient operations.
• Lead from an expectation that ensures Quality, Compliance, and Safety are core values. They must be givens in every aspect of operations from meeting production requirements to delivery of products as well as maintaining the facility. Ensure operation runs consistently within compliance of regulatory requirements (FDA, Health Canada, IVDR, GMP, etc) and defined company SOPs.
• Provide site leadership in operational management, strategic planning, compliance and quality assurance, site and stake holder communication, site culture and engagement, adoption of new systems, and financial commitments.
• Build and develop a team that is self-sufficient in executing the mission of the team in support of operations and one that develops future operational and technical bench strength. Mentor, coach and build high performance talent. Identify and select colleagues who have the right skill set and commitment to meeting elevated standards and our quality requirements.
• Implement and monitor safety programs, hazard assessments, and emergency response plans to protect employees and maintain compliance with occupational health and safety regulations.
• Lead and manage supply chain to ensure continuity of supply. Develop and execute global strategic supplier sourcing, tactical purchasing, and materials coordination to meet sales and distribution demand for finished. Strategic responsibility for purchasing functions, warehousing operations, Supply/ Demand Planning, and Master Production Scheduling.
• Ensure continuity of supply is maintained by managing end to end operations, including prompt resolution of any product or production related issues.
• Financial Oversight of the full site: Manage budgets, monitor expenses, and ensure financial targets are met.
• Drive a culture of quality, including ensuring the following are completed in a timely and effective manner: provide appropriate Subject Matter Expertise Support as necessary to support or lead investigations and actions tied to TrackWise (including ICAR’s, Deviations, OOS’s and Complaint investigations; completing all CAPA related and compliance support activities with fundamentally sound and robust actions; maintaining euipment and facilities to meet or exceed GMP requirements and ensure a clean, well organized and a safe environment.
• Establish strong working partnerships based on a commitment to teamwork and mutual accountability to ensure alignment on project priorities and goals. Must be able to work closely and communicate with other departments.
• Coordinate with other functions (Accounting; Quality; Marketing and R&D) to identify cost of goods drivers and identify process improvement projects linked to driving improvements in cost of goods.
• Must be able to interface with regulatory agencies for site audits.
• Performs other duties and responsibilities as assigned
• Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key Relationships:

• Employees at all levels of the organization – Foster a culture of collaboration, engagement, and safety awareness across all teams.
• External Regulatory Bodies – Maintain strong relationships and compliance with TUV, FDA, and other agencies; ensure readiness for audits and inspections.
• Vendors – Partner for audits and vendor assessments to ensure quality, reliability, and adherence to safety and compliance standards.
• Client Services – Collaborate to ensure successful delivery of products to customers and address any supply chain challenges proactively.
• Marketing – Align on forecasts and communicate any potential supply or safety-related disruptions.
• This position will network across all functional areas and levels within the organization as well as develop and maintain key relationships with the senior management team throughout Werfen Transfusion leadership team

Qualifications

Minimum Knowledge & Experience required for the position:

• Bachelors of Science degree required.
• Master’s degree preferred.
• Minimum of 8 years leading in Operations and Supply chain in a regulated and diagnostics environment required.
• Lean Training and/or Six Sigma Certification
• Experience in FDA regulated industries and knowledge of GMPs
• Experience building high performing teams and driving continuous improvement
• Experience in Aseptic Manufacturing
• Experience in automation and manual operations

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• Strong verbal and written communication skills, strong negotiation acumen
• Team development
• Works well with diverse groups of people, strong interpersonal skills
• High level of autonomy
• Working knowledge of Microsoft Office; extensive experience with large enterprise resource planning (ERP) system (SAP).

Travel requirements:

• Up to 10% of time, to include international travel

Closing

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact View email address on click.appcast.io for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.